35356-091 : 12 Hr Oxycontin 20 mg Extended Release Tablet

NDC:	35356-091
Labeler:	Lake Erie Medical Dba Quality Care Products LLC
Product Type:	Human Prescription Drug
Drug Name:	Oxycontin
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA020553
Rev. Date:	Jun 9, 2011
CSA Schedule:	CII (US) ^[1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	20;OC
Shapes:	Round
Colors:	Pink
Size (mm):	7
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

35356-091-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (35356‑091‑30)
35356-091-60: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (35356‑091‑60)
35356-091-90: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (35356‑091‑90)

Active Ingredients:

Oxycodone Hydrochloride

Dosage Strength:

20 mg

Inactive Ingredients:

Ammonio Methacrylate Copolymer Type B
Hypromelloses
Lactose
Magnesium Stearate
Polyethylene Glycol 400
Povidone
Sodium Hydroxide
Sorbic Acid
Stearyl Alcohol
Talc
Titanium Dioxide
Triacetin
Polysorbate 80
Ferric Oxide Red

Pharmaceutical Classes:

Full Opioid Agonists [MoA]
Opioid Agonist [EPC]

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.